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Administratie en secretariaat
#141858
Heverlee
Fulltime
03-08-2021
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Regulatory Affairs Administrator (m/v)

As a Regulatory Affairs (RA) administrator you’ll be responsible for providing administrative and technical support related to the daily activities of the supervisor, as well as managers, experts, specialists and officers.

-you’ll work with the different regulations that are applicable on the medical devices that the company produces.

-You possess the needed product knowledge, so that you can prepare both routine and more complex registration files.

-You’ll provide assistance in sending out and following up of notifications concerning changes.

-You’ll also be required to provide support regarding the applications of documents and certificates, that are needed for registrations.

-You’ll maintain the registration database, follow up on registration approvals and share all relevant information.

-You’ll perform tasks related to the labelling requirements & instructions for medical devices.

-You’ll provide support during the translations and evaluation processes of the labels.

-You’ll also be the one to keep record of all the external documents.

- you’ll assist in the handling of customer product complaints.

-You’ll provide administrative support in preparing, issuing and the follow-up of FSCA’s (Field Safety Corrective Actions.

-You’ll also be required to support the approval of return orders.

-One of your core responsibilities is the maintenance of the RA information in the diverse information systems.

Wat wij van jou vragen:

You possess a scientific bachelor’s degree and an additional interest in administrative tasks or an experience in administrative support for Regulatory Affairs.

Possessing knowledge and experience concerning regulations and quality systems for medical devices, will be regarded as an additional advantage.


You are fluent in English (written and verbal skills)

A proficiency in other languages will be regarded as an advantage.


You are familiar with Microsoft Office and you are open to learn to work with new software programs.

Knowledge of SAP is a plus.

In addition, you are accurate, organized and a team player.

Wat wij jou bieden:

We offer a full-time employment contract accompanied by an attractive salary package.

A work environment in which every associate, customer and business partner is treated with respect, where sincerity is key and where everyone always strives to find the most optimal solution.

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Diestsestraat 212-214
3000  Leuven

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